Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco [ Time Frame: Weeks 9 through 12 ] [ Designated as safety issue: No ]

Number of subjects who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL.

Secondary Outcome Measures:

Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use [ Time Frame: Week 9 through 12, Week 26 ] [ Designated as safety issue: No ]

Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.

Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.

Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26) [ Time Frame: Week 12, Week 26 ] [ Designated as safety issue: No ]

Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.

Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Other Name: Champix, Chantix, CP-526,555

Placebo Comparator: Placebo

Drug: Placebo

Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.

Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.

Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.

Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.

Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717093